There’s a lot riding on a drug sponsor’s selecting the right CDMO. Kim K. Burson, Head of Quality Assurance (QA) and Quality Control (QC) at Achaogen, has some advice for those initial audits. A critical component is the “witnessing" of standard operating procedures (SOPs) in action. Burson explains this, and also helps us separate the QC and QA functions.
Using a risk management tool such as preliminary hazard analysis, a periodic review frequency can be identified and applied to qualified equipment. This will enable a timely review of the equipment by means of pertinent data such as manufacturing performance trend data, change history, and/or deviation history.
This article is the second in a series examining strategies that allow quality groups to collaborate with GCP and GMP groups to improve ICH E6(R2) compliance, increase clinical study robustness, and enhance data integrity.
Often there is a great deal of confusion regarding why manufacturers wait so long to market their biosimilars despite having a more abbreviated pathway than innovator biologics. Other times, manufacturers and investors will be caught off-guard when a court blocks marketing of their biosimilars despite them having obtained FDA approval. Mitigating preventable uncertainty warrants understanding some of the underlying mechanisms related to the “patent dance.” This is the first of two articles that will address the patent infringement issues often used against biosimilars by sponsor biologic owners to delay or derail marketing of the biosimilar.
The aim of this white paper is to demonstrate how GE Healthcare Life Sciences single-use products can be applied in the field of vaccine manufacturing. The white paper includes a brief discussion around modern vaccine processes, followed by a case study showing the scale-up of upstream and downstream processes for the production of a cell based live attenuated influenza virus using single-use ReadyToProcess technology.
Capsular polysaccharides (CPS) of encapsulated bacterial pathogens can give rise to an effective immune response in humans, and are commonly used in vaccine production. This whitepaper offers an overview of modern tools and technologies that can facilitate CPS-based vaccine production. An alternative purification approach based on chromatography, replacing many of the ethanol and phenol extraction steps of the traditional process, is also presented. Using the proposed purification platform, 28 different CPS of three different species could be processed to high purity and yield in a secure and environmentally friendly way.
Biopharmaceutical executives must consider how outsourcing fits into their development and production strategy, as well as how to select the best CDMO partner for their business. Here’s a step-by-step guide to help make that decision.
Follow the paths of two companies as they learn how a science-led, risk-based development approach yields a more successful outcome in the long run.
Due to a paradigm shift in the pharmaceutical industry, there is rising pressure to come up with faster, more cost-effective ways to produce drugs for the patients who need them.
By dispelling the myths associated with biocatalysis, a manufacturer can reap the benefits of this technology, providing a route to greener, safer chemistry that delivers a higher overall yield.
A better strategy, coordination, and additional tools will help keep medicines and ingredients safe.
Biopharmaceutical executives must consider how outsourcing fits into their development and production strategy, as well as how to select the best CDMO partner for their business. Here’s a step-by-step guide to help make that decision.
Biopharmaceutical manufacturer’s goals are to develop a process that will deliver material for clinical trials quickly and smoothly, achieve success in these trials, and scale up to commercial manufacturing. Traditionally, column packing has been considered a bottleneck. Suboptimal packing is not only time-consuming, but can result in poor performance. By eliminating these two concerns, you can focus on the core process.
Trio’s lead compound TML-2 is the acetyl prodrug of TML-1, a novel, well tolerated G-protein coupled receptor antagonist which shows clinical promise but has limited bioavailability owing to low solubility. Trio turned to Catalent for help.
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About OutsourcedPharma.com
OutsourcedPharma.com provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and healthcare markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their bio and pharma sponsors.
This regulation from the FDA outlined serialization and traceability requirements spread over the course of 10 years with preparation for each phase accumulating into a potentially high overall price tag.
Help sponsors design a more holistic strategy to their managing the clinical supply returns process.
A problem with traditional mAb manufacturing is that there are so many potential entry points for microbial contamination. There are, however, ways to shut the door on contamination.
Ozonolysis is a widely used reaction in organic synthesis. The reaction was invented by Christian Friedrich Schoenbein in 1840. Alkenes and alkynes are the most common substrates for the ozonolysis reaction. Ozonolysis was an important diagnostic tool for the determination of the position of unsaturation in unknown molecules before the invention and development of spectroscopic techniques for identification and characterization of organic molecules. The reaction was used for structure elucidation work because it provided chemists with smaller and more readily identifiable carbonyl compounds.
The concept of Genotoxic Impurities (GI) and Potential Genotoxic Impurities (PGI) is defined in the ICH M7 (2014) and EMA (2006) guidelines. The focus of these guidelines are on DNA reactive substances – those when present at low levels have a potential to directly cause DNA damage and lead to mutations, thereby potentially causing cancer. For late stage compounds and marketed products, acceptable increased cancer risk is set at a theoretically calculated Threshold of Toxicological concern (TTC) level of 1.5 mg/day.
